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Good Manufacturing Practice (GMP) News

Regulatory News

Revision of European Commission Guideline on Good Manufacturing Practice for Medicinal Products

The European Commission has launched the public consultation on the revision of Annex 15: Qualification and Validation.

Stakeholders are invited to comment on this draft by 31st May 2014 at the latest.

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The PIC/s Guides to GMP

The PIC/s Guide to GMP have been updated. Of particular interest is the change to Chapter 4 on documentation which extends slightly on the EU GMPs that were updated in June 2011.
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Qualified Persons (QPs) please take note!

The EMA Draft Reflection Paper on use of interactive voice response (IVR) technology to justify not including reanalysis/expiry dating on the label for clinical supplies is proposing yet another task for the QP, please see the link below; the last date for comments is 15th February 2012.
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For those involved in advanced therapy medicinal products (ATMPs)

 A reminder that EMA has issued a Committee for Medicinal Products for Human Use (CHMP)/Committee for Advanced Therapies (CAT) position statement on Creutzfeldt-Jakob disease and advanced therapy medicinal products, effective June 2011. See link below.
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EC concept paper on the requirement for safety features in line with the falsified medicines legislation

The European Commission has issued a concept paper which has been published for consultation. Comments and suggestions are invited by 27th April 2012
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New Booklet Available

Quality in Research - Guidelines for working in non-regulated research The aim of this updated Guideline is to facilitate the stepwise and straightforward development of a value adding Quality System into any research institute. We have, in this second edition tailored our approach to help make the case for implementation essentially a 'no brainer'. In each section, we now review the risks posed by poor systems of work and exemplify, with real life examples or case studies, the consequences of non-robust research process. The potential steps which can then be taken to overcome such issues are highlighted, drawing on the original Guidelines as a basis, and then we indicate the additional benefits that good process often brings.

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